Benign prostatic hypertrophy (BPH) is one of the most common medical problems experienced by middle to older aged men. Urinary tract obstruction due to prostatic enlargement has been recognized since the earliest days of medicine. Hypertrophic enlargement of the prostate gland often leads to compression of the urethra resulting in obstruction of the urinary tract and the subsequent development of symptoms including frequent urination, nocturia, pain, discomfort, and embarrassment. The association of BPH with aging has been shown to exceed 50% in men over 50 years of age and increases in incidence to over 75% in men over 80 years of age. Symptoms of urinary obstruction occur most frequently between the ages of 65 to 70 when approximately 65% of the men in this age group have prostatic enlargement. Due to a continuing increase in life expectancy, the average age of the population of the United States is increasing. Accordingly, the number of men expected to develop clinical symptoms of BPH will also continue to increase.
Currently there is no effective nonsurgical method of treatment for BPH. Patients suffering from the obstructive symptoms of this disease are generally provided with only two options: continue to cope with the symptoms, or submit to surgical intervention. The incidence of BPH requiring surgical intervention has been found to increase progressively with age to a maximum of 11 per thousand in men more than 80 years of age. More than 350,000 patients per year undergo surgery for removal of prostatic tissue in the United States. It has been calculated that a 40 year old man has about a 10% chance of requiring a prostatectomy for benign disease if he lives to be 80 years old.
Those suffering from BPH are often elderly men, many with additional health problems that increase the risk of surgical procedures. Surgical procedures for the removal of prostatic tissue are associated with a number of hazards including: anesthesia associated morbidity; hemorrhage; pulmonary emboli; bladder perforation; incontinence; infection; urethral or bladder neck stricture; retention of prostatic chips; retrograde ejaculation; and impotence. Accordingly, a significant number of patients with symptoms severe enough to warrant surgical intervention are poor operative risks and are not able to undergo prostatectomy. There is no doubt regarding the need, importance, and value of an alternative nonsurgical method of treatment for those men who are poor surgical risks.
An alternative, nonsurgical method of therapy may be expected to yield savings in many areas such as: surgical costs; post-operative hospitalization; transfusion; antibiotics; out-patient visits; rehospitalization for complications; and other socio-economic costs related to recuperation and sick leave. The psychological complications of BPH in aging men due to loss of bladder control are significant. An alternative, nonsurgical form of therapy would improve the quality of life for many aging men in terms of frequency of urination, inconveniences, embarrassment, and loss of personal dignity. BPH is a disease with major costs for society. The development and implementation of an alternative nonsurgical therapy for BPH would provide major medical, economic, and psycho-social benefits.
Accordingly, a clear need exists for a safe, effective, nonsurgical treatment for prostatic hypertrophy. A further need exists for a treatment that poses little risk to the patient, is relatively inexpensive, and which can be performed as an out-patient procedure without the use of general anesthesia.